MARIS Study; Mediterranean Approach to Reduce Insulin-Resistance Study
Study Details
Study Description
Brief Summary
Background: During the 1990s, the prevalence of the metabolic syndrome in the Netherlands ranged from 3% in women of 20-39 yrs to at least 33% in men 55 yrs and older and it is expected to increasing. Prevention is therefore warranted. In this respect the amount and type of fat in the diet deserves attention. Recently, an intervention study reported that a diet high in mono-unsaturated fatty acids (MUFA) such as from olive oil, increased insulin sensitivity in healthy subjects. However, additional beneficial effects can be expected from the Mediterranean diet as a whole. Hypothesis: Replacing saturated fatty acids (SFA) by mono-unsaturated fatty acids (MUFA) will improve hyperinsulinemia and dyslipidemia, and a typical Mediterranean diet will even have more pronounced effects. Study objectives: To investigate the impact of the Mediterranean diet, and especially the intake of MUFA, on markers of the metabolic syndrome in high-risk subjects. Methods: The controlled dietary intervention will include 60 subjects aged 40-65 years with moderate abdominal obesity. After a run-in diet for 2 weeks they will be assigned randomly to receive one of the three diets for a period of 8 weeks. Measurements of serum insulin concentration and other parameters will be carried out at weeks 2 and 10. Expected results: Our study will provide information on the role of MUFA and the expected beneficial impact of other factors of the Mediterranean type of diet on the metabolic syndrome.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Outcome Measures
Primary Outcome Measures
- Fasting Insulin []
Secondary Outcome Measures
- Systolic/ diastolic blood pressure []
- plasma glucose []
- serum HDL-cholesterol []
- serum triglycerides []
- waist-hip circumference []
- serum total cholesterol []
- serum LDL-cholesterol []
- Blood sample will be stored for measuring markers of inflammation. []
- Additionally in half of the subjects insulin sensitivity will be measured by the euglycemic hyperinsulinemic clamp. []
- Molecular markers in fat and muscle biopsies []
Eligibility Criteria
Criteria
Inclusion Criteria:
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Waist circumference ≥ 94 cm for men or ≥ 80 cm for women
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Age from 40 to 65 years at the time of randomisation
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Written informed consent obtained
Exclusion Criteria:
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Unable or unwilling to comply with study procedures.
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The use of drugs for lowering serum cholesterol, serum triglycerides, blood pressure, or diabetes.
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Unusual dietary patterns, including high alcohol intakes
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Recent (< 4 weeks) or current participation in a study with any investigational drug or dietary intervention.
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High concentrations of total cholesterol (>8 mmol/L).
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Diabetes mellitus.
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Being pregnant or giving breastfeeding.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Hospital Gelderse Vallei | Ede | Netherlands | 6710 HN | |
| 2 | Wageningen University, Division of Human Nutrition | Wageningen | Netherlands |
Sponsors and Collaborators
- Wageningen University
- Netherlands Heart Foundation
- Unilever R&D
Investigators
- Principal Investigator: Edith JM Feskens, Dr., Division of Human Nutrition, Wageningen University
- Principal Investigator: Jeanne HM de Vries, Dr., Division of Human Nutrition, Wageningen University
- Principal Investigator: Lisette CP de Groot, Prof., Division of Human Nutrition, Wageningen University
- Principal Investigator: Lydia A. Afman, Dr., Division of Human Nutrition, Wageningen University
- Principal Investigator: Michael R. Muller, Prof., Division of Human Nutrition, Wageningen University
Study Documents (Full-Text)
None provided.More Information
Publications
- Esposito K, Marfella R, Ciotola M, Di Palo C, Giugliano F, Giugliano G, D'Armiento M, D'Andrea F, Giugliano D. Effect of a mediterranean-style diet on endothelial dysfunction and markers of vascular inflammation in the metabolic syndrome: a randomized trial. JAMA. 2004 Sep 22;292(12):1440-6.
- Panagiotakos DB, Polychronopoulos E. The role of Mediterranean diet in the epidemiology of metabolic syndrome; converting epidemiology to clinical practice. Lipids Health Dis. 2005 Apr 12;4:7. Review.
- Serra-Majem L, Roman B, Estruch R. Scientific evidence of interventions using the Mediterranean diet: a systematic review. Nutr Rev. 2006 Feb;64(2 Pt 2):S27-47. Review.
- Vessby B, Uusitupa M, Hermansen K, Riccardi G, Rivellese AA, Tapsell LC, Nälsén C, Berglund L, Louheranta A, Rasmussen BM, Calvert GD, Maffetone A, Pedersen E, Gustafsson IB, Storlien LH; KANWU Study. Substituting dietary saturated for monounsaturated fat impairs insulin sensitivity in healthy men and women: The KANWU Study. Diabetologia. 2001 Mar;44(3):312-9.
- NHS 2003B068